This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role).Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application

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